Lives at stake in drug patent clash

By defiantly licensing generic versions of patented medicines, Thailand late last year and Brazil a few weeks ago have severely tested global health policy and the global trade system itself.

A functional system would strike a judicious balance between the interests of drug companies, whose patents compensate them for the large investments required to develop lifesaving medicines, and the imperative to make them available to the world's poor. Instead, today we have a dysfunctional battle between pharmaceutical giants and governments of developing countries, each side claiming to champion the world's health needs and accusing the other of exploitation.

Widening access to medicine and managing looming health crises that depend on such access are too important to leave to factions behaving like opposed interest groups. The world community must find a way to balance these interests and step in before the problem grows out of control.

Left unchecked, this dilemma could undermine trade relations between the United States, where most advanced drug research and development is done, and Asia, where most of the generic manufacturing is located. Investors know that AIDS, SARS, avian flu and other diseases may threaten Asia's emerging economies, so drug access disputes in Asia also hurt their interests.

But economic issues aside, isn't equitable drug access a human right?

Thailand stood up for that right when it recently invoked World Trade Organization rules allowing compulsory licensing to override patent protections where compelling public health needs are at stake. Thailand used these rules to license generic manufacturing of the patented second-line HIV drug Aluvia, made by Abbott and originally priced at $2,200 per patient annually - considerably more than most Thais earn in a year. The generic makers can sell it for a third of that.

Big pharmaceuticals accuse Thailand of abusing WTO rules, violating intellectual property rights and undermining the financial incentive to develop new drugs. Abbott withdrew seven medicines from the Thai market and threatened not to introduce any more. Third parties ranging from Bill Clinton to Asian churches strongly endorse Thailand and Brazil's actions, arguing that while no pharmaceutical company's life depends on drug prices in the developing world, many patients' lives do.

The dispute strains U.S.-Thai relations, as the United States has sent mixed signals - putting Thailand on its Priority Watch List for violating intellectual property rights while acknowledging compulsory licensing was legal, then denying that listing Thailand had anything to do with compulsory licensing, then saying the licensing was one factor among others. The Thai government says it simply wants to negotiate a deal with the patent holders to sell HIV drugs at prices ordinary citizens can afford, though, as Thai Health Minister Dr. Monkol Na Songkhla told the Asia Society in a recent online interview, "No company or patent holder wants to talk about lowering the price or sharing a drug with poor people."

Yet recently, Abbott and Thailand did talk about it. Abbott offered to sell Aluvia for $1,000 per patient annually, while Thailand reiterated it will refrain from compulsory licensing only if Abbott beats the generic price of $695. If fighting over that $300 difference while lives hang in the balance seems petty, it may also be a sign that the two sides are not so far apart this time.

But the issue is much bigger than one HIV drug in one country. Cancer, heart disease, diabetes and other chronic illnesses loom large throughout the developing world, and so does the issue of access to medication to treat them. Brazil and Thailand recently announced they will cooperate on a range of health care issues. This is a positive sign that as their drug needs grow, developing countries could organize and exert collective power on pricing and generic licensing.

The flawed patent system, the WTO's disputed Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and activism by governments of affected developing countries cannot adjudicate these complex issues adequately. It's time for a comprehensive, multilateral solution to the problem of drug access.

In advance of the Group of Eight summit this week, news leaked that G-8 governments will press pharmaceutical companies to cut prices for medications that the poor need. The G-8 countries support all aspects of TRIPS, including the right of compulsory licensing, and can do much else to reaffirm WTO intellectual property rules, including not pressuring developing countries into trade agreements that destabilize them. The WHO Commission on Intellectual Property Rights, Innovation and Public Health is working to create alternatives to the arguably perverse incentives that encourage pharmaceuticals to invest billions researching new drugs and then price them out of reach of developing countries.

The World Health Assembly, the primary decision-making body for the WHO, just resolved at its meeting in Geneva to make this matter a priority by bringing together member states, the European Commission and a range of government agencies to form a working group on the issue. There is also agreement that civil society and the pharmaceutical industry should be involved. The hope is that by working together, the interested parties can produce a global plan of action.

All this comes none too soon. Multilateral leadership and creative thinking could yet find an equitable balance between the interests of patent holders and the interests of global health and human rights. For now, though, they remain on a collision course.

Elizabeth H. Williams is the acting director of the Asia Society's Initiative on HIV/AIDS and Global Health. Her e-mail is elizabethw@asiasoc.org.